Status:
COMPLETED
Evaluation of the Next Generation WATCHMAN LAA Closure Technology in Non-Valvular AF Patients (EVOLVE)
Lead Sponsor:
Boston Scientific Corporation
Conditions:
Atrial Fibrillation
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
This study will evaluate the next generation WATCHMAN Left Atrial Appendage (LAA) Closure Device as implanted in patients with non-valvular atrial fibrillation (AF) with a CHADS2 stroke risk stratific...
Eligibility Criteria
Inclusion
- Key
- Paroxysmal, persistent, or permanent non-valvular atrial fibrillation
- Eligible for long-term Warfarin therapy;
- Eligible to come off Warfarin therapy if the LAA is sealed
- Calculated CHADS2 score of 1 or greater
- Key
Exclusion
- New York Heart Association Class IV Congestive Heart Failure
- Recent MI (within 3 months)
- ASD and/or atrial septal repair or closure device
- Resting heart rate \>110 bpm
- Has an implanted mechanical valve prosthesis
- Left atrial appendage is obliterated
- Has undergone heart transplantation
- Has symptomatic carotid disease
- Contraindicated for aspirin
- LVEF \< 30%
- Cardiac Tumor
Key Trial Info
Start Date :
May 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2013
Estimated Enrollment :
69 Patients enrolled
Trial Details
Trial ID
NCT01196897
Start Date
May 1 2009
End Date
November 1 2013
Last Update
December 8 2015
Active Locations (3)
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1
NA Homolce Hospital
Prague, Czechia, 150 30
2
Krankenhaus der Barmherzige Bruder
Regensburg, Bavaria, Germany, 93049
3
Sankt Katharinen Hospital / Cardiovasculares Centrum
Frankfurt, Germany, 60389